Back to results

Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM) (MMI4MSM RCT)

Primary Purpose

Human Immunodeficiency Virus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HealthMindr Application

Waitlist

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring AIDS, Behavioral Science, Infectious Diseases, Health Promotion, Sexually Transmitted Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Assigned male at birth
Current, self-reported gender identity as "Male"
Aged 18 or over
Self-reported ability to read and understand English-language
Resides in the Atlanta, Georgia (GA), New York, New York (NY), or Detroit, Michigan (MI) Metropolitan Statistical Area.
Self-reported anal sex with a male partner in the past 12 months
Owns and uses an Android or Apple (iOS) smartphone
Is included in one of the following risk groups, by self-report:
- HIV seropositive
- HIV seronegative at "higher risk" (condomless anal sex and not taking PrEP as prescribed in the past 3 months)
- HIV seronegative at "lower risk" (no condomless anal sex in the past 3 months, or condomless and sex while taking PrEP as prescribed in the past 3 months)

Exclusion Criteria:

Currently participating in another HIV prevention research study or program
Participant's phone or device does not support HealthMindr application
Tested positive for HIV for the first time in the past 6 months
Has a plan to move out of the Atlanta, GA, New York, NY or Detroit, MI, Metropolitan Statistical Area within in the next 9 months

Sites / Locations

Emory University
University of Michigan
Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HealthMindr Application

Waitlist

Arm Description

Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months.

Participants in this study arm will not have access to the mobile messaging application during the course of the study. After the Month 9 follow up assessment participants in this study arm will be offered access to HealthMindr.

Outcomes

Primary Outcome Measures

Change in HIV testing

HIV-negative men will be asked if they have received an HIV test (ever for the baseline measure and in the past 3 months for follow up surveys).

Change in engagement in HIV care

HIV-positive men will be asked if they have seen a doctor, nurse, or other health provider for HIV care (ever for the baseline measure and in the past 3 months for follow up surveys).

Change in antiretroviral therapy (ART) uptake

HIV-positive men will be asked if they have ever been prescribed and taken antiretroviral medications to treat HIV.

Change in ART adherence

HIV-positive men currently taking antiretroviral medications to treat HIV will be asked if they have been taking their ART as prescribed in the past 3 months.

Change in engagement in HIV preventative care

HIV-negative men will be asked if they have seen a doctor, nurse, or other health care provider (ever for the baseline measure and in the past 3 months for follow up surveys).

Change in pre-exposure prophylaxis (PrEP) uptake

HIV-negative men will be asked if they are taking PrEP (baseline measure) or if they began taking PrEP in the past 3 months (for follow-up measurements).

Change in PrEP adherence

HIV-negative MSM currently taking PrEP will be asked if they have been taking their PrEP medication as prescribed during the past 3 months.

Change in condom use compliance

Proportion of men reporting 100% condom use (stratified by partner type) during the prior 3 months.

Change in condom use

Participants will be asked if they have had any anal sex in which a condom was not used from start to finish in the past 3 months.

Change in testing for sexually transmitted infections (STIs)

Sexually active participants will be asked if they have been tested for STIs in the past 3 months.

Secondary Outcome Measures

Change in intention to engage in preventive behaviors

Participants will report how likely they are to engage in preventive behaviors (such as taking PrEP or ART and increasing condom use) over the next 3 months. Intention to engage in preventive behaviors will be assessed by 11 questions, designed for this study, which are answered on a scale of 1 to 5 where 1 = "definitely not likely" and 5 = "definitely likely". Summed scores can range from 11 to 55 where higher scores indicate increased intention to engage in healthy activities related to HIV prevention and care.

Change in intention to engage in risky behaviors

Participants will report how likely they are to engage in risky behaviors (such as missing doses of PrEP or ART and not using a condom) over the next 3 months. Intention to engage in risky behaviors will be assessed by 3 questions, designed for this study, which are answered on a scale of 1 to 5 where 1 = "definitely not likely" and 5 = "definitely likely". Summed scores can range from 3 to 15 where higher scores indicate increased intention to engage in risky activities related to HIV prevention and care.

Change in intention to seek information

Participants will report how likely they are to seek out information on HIV prevention during the next 3 months.

Change in intention to seek treatment

Participants will report how likely they are to seek out HIV treatment during the next 3 months.

Change in communication with partner

Participants will be asked if they have talked with their sexual partners about ART or PrEP treatment (depending on HIV status) during the past 3 months.

Full Information

NCT ID

NCT03666247

First Posted

September 10, 2018

Last Updated

January 3, 2020

Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03666247

Brief Title

Mobile Messaging Intervention to Present New HIV Prevention Options for Men Who Have Sex With Men (MSM)

Acronym

MMI4MSM RCT

Official Title

Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

January 24, 2018 (Actual)

Primary Completion Date

December 18, 2019 (Actual)

Study Completion Date

December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures among men who have sex with men (MSM) by determining whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll men into a randomized controlled trial. Participants randomized to the messaging intervention will have access to a smartphone-based messaging platform for three months while those assigned to the waitlist group will be offered access to the messaging platform after all follow up is complete. Participants will complete surveys at baseline, after the end of the 3 month intervention, and follow up surveys 6 and 9 months after the baseline survey.

Detailed Description

This study aims to evaluate the use and effectiveness of a smartphone-based messaging platform as a public health strategy for improving participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll 1,206 men into a randomized controlled trial. They will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the messaging app upon randomization to that group. All men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 9-month follow-up period. When the intervention arm activities and assessments have concluded, participants in the waitlist-control arm will then be given the option of accessing to the intervention app and participation in intervention post-test activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

AIDS, Behavioral Science, Infectious Diseases, Health Promotion, Sexually Transmitted Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1229 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HealthMindr Application

Arm Type

Experimental

Arm Description

Participants in this study arm will have access to the mobile messaging platform (HealthMindr) for 3 months.

Arm Title

Waitlist

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

HealthMindr Application

Intervention Description

From baseline to 3-month post-test, participants in the intervention arm are granted access and instructed to interact regularly with the HealthMindr messaging platform. The HealthMindr messaging platform delivers messages relevant to both general audiences of sexually-active MSM, as well as messages relevant only to specific subgroups of HIV-positive men, and currently higher and lower risk HIV-negative men. Answers provided during the assessments determine which subset of messages are delivered to app users, with information such as HIV status, changes in self-reported risk behaviors, or other factors that influence the relevance of any given message. The HealthMindr application also offers free condoms, lube, and a HIV and STI testing kits.

Intervention Type

Behavioral

Intervention Name(s)

Waitlist

Intervention Description

Participants assigned to the waitlist-control arm will be given a welcome sheet orienting them to the study. The message they view will include the same resources links provided to the intervention arm. The information will cover the importance of testing, links to an online mapping tool about the HIV epidemic in the United States (AIDSVu) and resources to locate HIV testing services and prevention information in their area. No information recommending frequency of testing will be given in the welcome greeting.

Primary Outcome Measure Information:

Title

Change in HIV testing

Description

HIV-negative men will be asked if they have received an HIV test (ever for the baseline measure and in the past 3 months for follow up surveys).

Time Frame